Regulators are warming to real-world evidence in device submissions, but the FDA has identified a recurring failure mode: ...

US FDA counters concerns about rising rates of complete response letters with a longitudinal analysis showing long-term ...

The GENEROUS pilot is a closed club – limited to the 26 drug makers that already struck MFN deals with the Trump administration. The program's prices, and even which products are part of it, are still ...

FDA's drug review chief wants artificial intelligence to do what regulators can no longer do after a wave of retirements: ...

Electra Therapeutics raised $350m, bringing the biopharma IPO total in the US to 21 offerings this year. Also, Halozyme ...

The company filed for approval of the drug in focal seizures, but it paused new enrollment in psychiatric studies due to adverse events.

The FDA granted full approval to Lilly’s oral SERD imlunestrant, expanding its label from monotherapy to include combination ...

After the European Medicines Agency upheld its negative opinion for Xervyteg, MaaT Pharma said it was evaluating strategic funding options to strengthen the drug's evidence package and pursue future ...

New treatments from AstraZeneca and Xcovery/Betta Pharmaceuticals for generalized myasthenia gravis and ALK-positive advanced non-small cell lung cancer, respectively are on track for EU-wide ...

A positive opinion from the European Medicines Agency’s human medicines committee, the CHMP, has put Incyte’s Povofortay on track for EU marketing approval, while the therapy remains under review in ...

Just Eat Takeaway's health and beauty lead Katie Hanlon told delegates to the recent PharmaSynergyOTC conference in Rome that on-demand delivery is a pharmacy channel with its own basket, its own ...

The European Medicines Agency has endorsed Novo’s Frehemgo for hemophilia A, clearing the decks for its EU marketing approval.